iqa auditor training
DESCRIPTION
QMS ISO 9001 -2008 Internal Quality Auditor TrainingTRANSCRIPT
QMS Internal Auditor Training
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 0
Sandip R [email protected]
Table of contents
Section 1 : Introduction to Quality Management
Section 2 : Overview of ISO 9001:2008
Section 3 : Overview of clauses
Section 4 : Quality System Audits
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 1
Section 4 : Quality System Audits
Section 5 : Conducting and managing an Audit
Section 6 : Non conformity report
Course Introduction
� Describe the purpose of QMS and Explain the 8 princ iples of quality management
� Explain purpose , content and interrelationship of ISO 9000, ISO 9001 and ISO 9004
� Explain the role of an auditor to plan , perform, report & follow
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 2
� Explain the role of an auditor to plan , perform, report & follow up an audit.
What is Quality?
“ Degree to which a set of inherent
characteristics fulfils requirements”You tell me what does the quality
mean to you ?
You have the
”official”
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 3
----- ISO 9000
mean to you ?”official” definition ,
BUT…..
What is Quality ?
Quality Characteristics
� Technological - Inductance , Power, THD
� Psychological : taste, aesthetics, status
� Time oriented – reliability , maintainability,
availability
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 4
availability
� Contractual – compliance to standard,
guarantee / warranty
� Ethical - Courtesy of sales personal,
Honesty , confidentiality
What is Quality ?
in that case ,which is of a better quality?
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 5
QMS
QMS
A set of co-ordinated activities to direct and control an
organization in order to continually improve the
effectiveness and efficiency of its performance.”.
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 6
effectiveness and efficiency of its performance.”.
Why do you think , we need a quality
management system?
Need of QMS
� To be near to the center as possible when aiming at the moving target which we call quality
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 7
Introduction to QMS
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 8
How do you think that ISO 9001:2008 could help?
QMS Principles
From ISO 9000:2000
� Customer focus
� Leadership
� Involvement of people
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 9
� Process approach
� System approach to management
� Continual improvement
� Factual approach to decision making
� Mutual beneficial supplier relationships
Customer Focus
Customer Organizations depend on their customers
Quality of
But never forget the other interested
parties
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 10
Product/service
SHAREHOLDERS SUPPLIERS SOCIETY EMPLOYEES
Return on Business Respo nsible Personal
Investment continuity Beha vior Development
Leadership
Leadership Provide:
� Unity of purpose
� Direction
� Internal environment
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 11
Involvement of people
People are the essence of the organization .
Their full involvement enables using their
abilities to the benefit of the organization .
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 12
Process Approach PROCESS
EFFECTIVENESSExtend to which planned activities are realized and planned results achievedCONTROLS
PROCESS“Set of interrelated
activities which transforms inputs
INPUT OUTPUT PRODUCT
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 13
A desired result is achieved more efficiently when activities and related resources are managed as a process.
which transforms inputs into outputs”
INPUT OUTPUT
RESOURCES
PROCESS EFFICIENCYRelationship between the result
achieved and the resources used
PRODUCT
System approach to Management
Identifying, understanding and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its objectives
R I R
I o I o ProcessA
ProcessB
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 14
C R C R
I = INPUT I o I o
O = OUTPUT
R = RESOURCES C I C
C = CONTROLS
C
A
ProcessD
ProcessC
B
Continual Improvement
The methodology known as
“Plan-Do-Check-Act”
Can be applied to all processes of the QMS
Act : Take actions to Plan : Establish objectives and process
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 15
Continually improve necessary to deliver results in
Process performance. accordance with customer
requirements and the organization's
policies.
Check : Monitor and measure Do : Implement the processes.
Processes and product against policies,
Objectives and requirements for the
Product and report the results
Factual Approach to Decision Making
Effective decisions are based on the analysis of da ta and
Information
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 16
Mutually beneficial supplier relationship
An organization and its suppliers are interdependent.
A mutual beneficial relationship enhances the ability of bo thto create value.
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 17
Other benefits?
Are there any other benefits
that a management system
can bring to an organization?
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 18
can bring to an organization?
Why a Quality Management System?
Organization improvement
Customer requirement
Market positioning
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 19
Customer requirement
Legal requirement
Supplier development
QMS Leads to Profitability
Improved morals & motivation of
staff
Improved internalTransfer of know
how
IncreasedProfitability
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 20
staff
Increasedcompetitiveness
ReducedQuality costs
Enhanced customerSatisfaction & loyalty
Why certification of the QMS?
Certification of quality system to ISO 9001 as a “Bo nus”:
� Tangible proof that the company’s quality system complies withinternationally recognized standard.
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 21
� Avoidance of multiple second party audits.
� Marketing edge
Why Quality Management System is Necessary?
Environment health &
Requirements Of society safety social AccountabilityISO14000OHSAS 18001
SA 8000
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 22
Sector Automobile
Requirements Telecom
Aeronautical
Market Access Manufacturing services
TS 16949TL 9000EN 9100
ISO9000
Over view of ISO 9001:2008
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 23
Over view of ISO 9001:2008
ISO 9000:2000 FAMILY
Quality management system
fundamentals & vocabularyISO9000
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 24
Quality management system Quality management system guidelines for performance requirements
improvement
ISO9004
ISO9001
Process Approach
� Process approach to Quality management.
� Introduces the process model as conceptual presentation of QMS requirements.
Process Process
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 25
input outputProcessActivities
+Resources
ProcessA
ProcessB
ProcessD
ProcessC
Continual Improvement Cycle
The model of a Quality Management System provided in this
standard follows the methodology known as
“Plan-Do-Check-Act” (PDCA)
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 26
QMS Model
CUST
R
CUS
SATISF
Continual improvement of the Quality Management System
Management Responsibility
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 27
INPUT OUTPUT
TOMER
REQUIREMENT
STOMER
FACTION
Product
ResourceManagement
Measurement Analysis
& improvement
Product Realization
Relationship with ISO 9004
Consistent pair
Complement each other
Can be used as stand alone
Different scope -similar structure
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 28
Different scope -similar structure
ISO9001
ISO9004
Focuses on Effectiveness & is Certifiable
Aims on improvingPerformance & Efficiency
Scope
� The standard specifies QMS requirements for use to: -
� Demonstrate organization's ability to consistently Provide product meetingcustomer & applicable Regulatory requirements.
� Enhance customer’s satisfaction through effective application of the system,including processes for its continual improvement and assurance of conformity tocustomer and applicable regulatory requirement.
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 29
customer and applicable regulatory requirement.
NOTE:
Product = only product intended for or required by customer .
Application
� Requirements are generic
� Requirement may be excluded if cannot be applied du e to the nature of organization and its product.
� Exclusions must:
• Not affect ability or responsibility to provide conforming product
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 30
• Not affect ability or responsibility to provide conforming product
• Be limited to requirements in clause 7
(CI.4.2.2:”Details of & justification for any exclusion to be included in the quality manual”)
� Conformity to ISO 9001 may not be stated if exclusi ons go beyond above
Document
� For dated references, amendments to, or revisions o f, quoted publications do not apply.
� Users encouraged to use most recent revision for un dated reference
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 31
� Users encouraged to use most recent revision for un dated reference
� ISO 9000:2005 Quality Management Systems fundamenta ls & vocabulary.
� Note –
Product = services
Overview of
ISO 9001:2008
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 32
ISO 9001:2008
Clause 4 to 8
Quality Management System
CUST
R
CUS
SATISF
Continual improvement of the Quality Management System
Management Responsibility
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 33
INPUT OUTPUT
TOMER
REQUIREMENT
STOMER
FACTION
Product
ResourceManagement
Measurement Analysis
& improvement
Product Realization
4. Quality Management System
4.1 General requirements
4.2 Documentation requirements
4.2.1 General
4.2.2 Quality Manual
4.2.3 Control of documents
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 34
4.2.3 Control of documents
4.2.4 Control of records
Documentation Requirements
Quality Management System documentation can include :
� Documented statements of quality policy and quality objectives
� A quality manual
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 35
� Documented procedures required by the standard
� Documents needed by the organization to ensure effe ctive planning , operation and control of its processes and records.
What is a document ?
1.What is a document?
2.Why do you think we need a Documented System?
3.How many documents do you think we need in a syst em?
4.What format should it take?
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 36
4.What format should it take?
What is a document?
5.How should it all be controlled?
6.What is the typical structure of such a system?
7.Why do we need a quality manual?
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 37
7.Why do we need a quality manual?
8.How many documented procedures are prescribed by ISO 9001:2008?
9.Why do we need records?
5.Management Responsibility
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 38
5.4 Planning
5.4.1 Quality Objective
5.4.2 Quality Management System Planning
5.6 Management Review
5. Management Responsibility
5.5 Responsibility , Authority & Communication
5.5.1 Responsibility and Authority
5.5.2 Management Representative
5.5.3 Internal Communication
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 39
5.5.3 Internal Communication
5.6 Management Review
5.6.1 General
5.6.2 Review Input
5.6.3 Review Output
5.Management Responsibility
1.Who are Top Management in an organization?
2.Why do we need Top Management support for a QMS?
3.What do Top Management do in the organization?
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 40
4.Who sets and writes the Quality Policy?--WHY?
5. Who sets and writes the Quality Objectives?--WHY ?
6.Why do we need a Management Representative?
7.What does the Management Representative do?
5. Management Responsibility
8.Why do we need to define Responsibilities and Aut horities?
9.What advantages would this give us?
10.Why do we need Management Reviews?
11.What is their purpose?
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 41
11.What is their purpose?
12.What are we trying the achieve through them?
13.What information should be submitted as input?
14.What information is expected as output?
Quality Objectives
Clause 5.4.1 Quality Objectives requires objectives to be measurable . When measuring objectives , we need th ree pieces of information:
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 42
1.The situation NOW.
2.The situation we want to Achieve.
3.How long are we going to allow to achieve them.
Quality Objectives
S.M.A.R.T. :-
S.M.A.R.T. is a useful “SYSTEM ” for setting and monitoring objectives.
S = Specific
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 43
S = Specific
M = Measurable
A = Ambitious
R = Realistic
T = Time-bound
Quality Objectives
Objective 1
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 44
To reduce preparation of defective demand drafts
By 5%.
Quality Objectives
Objective 2
Reduce waiting time for orthopaedic surgeries.
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 45
Reduce waiting time for orthopaedic surgeries.
Quality Objectives
Objective 3
Reduce customer complains to zero.
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 46
Reduce customer complains to zero.
Quality Objectives
Objective 4
Develop new 10 business territory by year end.
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 47
Develop new 10 business territory by year end.
Quality Objectives
Objective 5
To reduce the purchase cost from present level of
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 48
To reduce the purchase cost from present level of
40% to 35% by end of this financial year.
Quality Objectives
Objective 6
To increase profitability from present level of
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 49
To increase profitability from present level of
11% to 20% during this financial year.
Quality Objectives
Objective 7
To increase production of 34.5 million tonnes /man per year
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 50
To increase production of 34.5 million tonnes /man per year
To 100 million tonnes/man per year.
Quality Objectives
Objective 8
To ensure uninterrupted power supply.
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 51
To ensure uninterrupted power supply.
Quality Objectives
Objective 9
To achieve 10% reduction in the cases of power fail ures.
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 52
To achieve 10% reduction in the cases of power fail ures.
6. Resource Management
6.1 Provision of Resources.
6.2 Human Resources.
6.2.1 General.
6.2.2 Competence , Training and Awareness.
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 53
6.2.2 Competence , Training and Awareness.
6.3 Infrastructure.
6.4 Work Environment.
6. Resource Management
1.Who decides the resource levels in the organizati on?
2.Do we need a recruitment policy? WHY?
3.How can we determine the competencies for a job?
4.What training , or other action , can we provide?
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 54
5.How can we prove evidence of training and compete ncies?
6.What examples of infrastructure need to be consid ered?
7.What examples of work environment need to be con sidered?
7. Product Realization
7.1 Planning of Product Realization.
7.2 Customer related process.
7.2.1 Determination of requirements related to the product.
7.2.2 Review of requirements related to the product .
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 55
7.2.3 Customer Communication.
7.3 Design and Development
7.3.1 Design and Development Planning.
7.3.2 Design and Development Inputs.
7.3.3 Design and Development Outputs.
7. Product Realization
7.3.4 Design and Development Reviews.
7.3.5 Design and Development Verification.
7.3.6 Design and Development Validation.
7.3.7 Control of design and development changes.
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 56
7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased product
7. Product Realization
7.5 Production and Service production .
7.5.1 Control of production and service provision.
7.5.2 Validation of processes for production &
service provision.
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 57
service provision.
7.5.3 Identification and Traceability.
7.5.4 Customer property.
7.5.5 Preservation of product.
7.6 Control of Monitoring and Measuring devices.
7. Product Realization
1.What facilities are needed in place before we sta rt any ‘Production’?
2.Where do we get customer requirements from?
3.What do we need to know before we can accept “An order/
A contract”?
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 58
A contract”?
4.Why do we need a focal point for the customer to contact?
5.Can we exclude any of the subparts of 7.3 Design & Development?
6.Why do we need to control design & development ch anges?
7.Why do we need to control supplier?
7. Product Realization
8.What methods may be used to assess the abilities of suppliers?
9. What information should we give suppliers when w e place an order?
10. How much incoming inspection should we apply?
11.When would we need to visit suppliers ?
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 59
11.When would we need to visit suppliers ?
12.What control conditions do we need in place befo re production?
13. Which processes need to be controlled by clause 7.5.2 ?
14. Is identification & Traceability always necessa ry?
7. Product Realization
15. What items could be termed “Customer Property”?
16.Why would we need to “Preserve Product” ?
17.Do all Measuring /Monitoring devices have to be calibrated?
18. What happens if there is no recognized standard for calibration?
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 60
calibration?
19.How often do we need to calibrate instruments?
20.What methods can be used to identify calibration status?
21. Do we need to check computer software used for testing?
22. Do we have to have a procedure for calibration?
8. Measurement Analysis Improvement
1.Are statistical techniques required to be determi ned?
2.List some methods which may be used to determine customer satisfaction ?
3.Do internal auditors have to be trained?
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 61
3.Do internal auditors have to be trained?
4.Who is responsible for the implementation of corr ective actions?
5. Who is responsible for creating the audit progra m ?
6.Can the frequency of audits be varied in differen t areas?
8. Measurement Analysis Improvement
7.What are audit “Follow -up” activities?
8.Do all processes have to be measured?
9.Do all processes have to be monitored?
10.How often do we have to monitor & measure the pr oduct?
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 62
10.How often do we have to monitor & measure the pr oduct?
11. What methods may be used to deal with non confo rming product?
12.What is the difference between “corrections” and
“corrective actions”?
8. Measurement Analysis Improvement
13. Why must we analyze data ?
14. Where in a QMS can we achieve continual improve ment?
15. What is the difference between “Corrective Acti ons ” &
“ Preventive Actions ”?
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 63
“ Preventive Actions ”?
16. Do we always have to implement Corrective Actio ns and/or
Preventive Actions ?
Quality System Audits
Quality System Audits
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 64
Quality System Audits
What is an Audit Process?
What is an Audit ?
“systematic ,independent and documented
process of obtaining audit evidence and
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 65
process of obtaining audit evidence and
evaluating it objectively to determine the
extend to which audit criteria are fulfilled”
ISO 9000:2005
Types of Audits
First Party Audit
Self-audit (Client , auditor and auditees are inter nal)
Second Party Audit
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 66
Second Party AuditAudit by an interested body (like a customer)
Third Party AuditAudit by independent body(Certification/registratio n body)
Objectives of an Audit
1. To verify conformance to requirements for certifi cation.
2.To verify conformance to contractual requirements .
3. To obtain and maintain confidence in the capabili ty of
a supplier.
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 67
a supplier.
4. To contribute to the improvement of the managemen t system
5. Approval / Evaluation of a supplier.
6. Major Quality Issues.
Factor influencing an Audit
1. Scope of QMS , Objective , Duration & Frequency o f the audit.
2. The Number, Importance, Complexity, Similarity an d Locations of the activities to be audited.
3. Results of the previous audits ,Status and Importan ce of the
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 68
3. Results of the previous audits ,Status and Importan ce of the activity.
4. Language ,Cultural & Social issues.
5. Significant changes to an Organization or its Op erations.
Responsibilities of Audit Team Leader
� To establish the objectives ,scope and extent of au dit program.
� To establish the responsibilities, procedures & ens ure resources are provided.
� Ensure implementation of audit program.
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 69
� Ensure implementation of audit program.
� Monitor, review and improve the audit program and maintain relevant documentation.
Resources for the Audit Program
� Financial and human resources (Auditors),Technical Experts.
� Processes to achieve and maintain the competence of
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 70
� Processes to achieve and maintain the competence of auditors and improve their performance.
Responsibilities of an Auditor
� To plan & organize the work effectively.
� To conduct Audits within scheduled timeframe.
� To prioritize and focus on matters of significance .
� To gather objective evidence through effective inte rviewing,
listening , observing and reviewing documents ,reco rds
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 71
listening , observing and reviewing documents ,reco rds
& data.
� To verify the data against the audit criteria to su pport audit
conclusion.
� To prepare appropriate , factual and accurate audit report.
� To communicate effectively with the auditee.
Audit Procedures & records
Audit Program Procedures:
� Planning and scheduling audits,
� Selection of audit team, team leader and appropriat e technical /
process expert .
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 72
� Conducting audits and audit follow -up.
� Monitoring the performance and effectiveness
of the audit program.
� Completion of the audit program .
� Maintaining audit records.
Audit Program Records
� Audit plans.
� Audit Reports.
� Non conformity reports.
� Corrective action reports and audit follow up , if any
� Records related to auditor’s competence and perform ance
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 73
� Records related to auditor’s competence and perform ance evaluation.
Competence & Evaluation an Auditor
Personal Attributes
Desired :
Ethical Perceptive Self Reliant
Open Minded Tenacious Decisive
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 74
Diplomatic
Undesired :
Critical Over-conclusive Indecisive
Aggressive Argumentative Susceptible
Inconsiderate Devious
Knowledge & Skills
� Applications of Management System to different
organizations
� General business processes and related
terminology .
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 75
terminology .
� Applicable laws, regulations .
� Quality Management Principles ,tools & their
applications .
� Processes and product including services ; technica l characteristics , specific processes and practices .
Principles of Auditing
� Ethical Conduct –The foundation of professionalism.
� Fair PresentationThe obligation to report truthfully.
� Due Professional Care
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 76
� Due Professional CareThe application of diligence & judgment in Auditing .
� IndependenceThe basis for impartiality of the audit &objectivit y of the audit conclusions.
� Evidence Based ApproachThe rational method for reaching reliable and repro ducible audit conclusions in a systematic audit process.
Managing & Performing
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 77
an Audit
Managing an Audit Program
o Audits must be well managed to provide good VALUE t o the Client / Auditee
� Audit team leader has the overall responsibility an d authority.
� Team members to assist the team leader.
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 78
o Good Audit Management Requires :
� Good planning & preparation
� Effective communication (Client , Auditee & Audito rs).
� Accurate & Objective fact finding.
� Effective completion of the audit.
Quality Management System
Reference: ISO19011
6.2 Initiating the Audit
6.3 Conducting document review
6.4 Preparing for on -site activities
20%
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 79
6.7 & 6.8 Completion & Follow-up
6.4 Preparing for on -site activities
6.5 Conducting the on-site Audit
6.6 Audit reporting
60%
10%
10%
Stages in an Audit A. Initiating the Audit
� Appointing the audit team leader.
� Defining audit objectives ,scope and criteria.
� Determining the feasibility of audit.
� Selecting the audit team
� Establishing initial contact with the auditee.
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 80
� Establishing initial contact with the auditee.
B. Conducting Document Review� Review of QMS documents & records.
� Preliminary site visit may also be conducted.
� Decision whether on site is required or not.
Stages in an Audit
C. Preparing for ON SITE audit activities
� Preparing audit plan (objectives ,criteria ,audit scope ,dates ,places of
audit)
� Assigning work to the audit team (Team member ,Technical experts)
� Preparing working documents (Check list ,Sampling plans ,NCR forms ,Audit
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 81
� Preparing working documents (Check list ,Sampling plans ,NCR forms ,Audit
report forms)
� Logistic arrangements
� Matters relating to confidentiality
� Acceptance of audit plan by client / auditee
Stages in an Audit
D. Conducting the on-site audit activities
� Conducting opening meeting
� Communication during the audit
� Role & responsibilities of guides and observers
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 82
� Collecting and verifying information
� Generating audit findings
� Preparing audit conclusions
� Conducting closing meeting
Stages in an Audit
E. Preparing ,Approving & distributing the Audit Repor t
� Audit objectives ,scope ,audit criteria.
� Processes / functions audited.
� Identification of audit client.
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 83
� Identification of audit team leader & member.
� Dates & places where audit conduced.
� The audit findings & Conclusions.
Stages in an Audit
�Preparing ,Approving & distributing the Audit Repor t
� The Audit plans.
� List of auditee representatives.
� Any areas not covered ,although covered within audi t scope.
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 84
� Any unresolved issues between audit team & auditee.
� Recommendation for improvements.
� Agreed follow up actions ,if any
� Distribution list of the report.
Stages in an Audit
F. Completing the audit
� Audit is complete when the report is prepare and
distributed to all concerned.
� Confidentiality of the information obtained during the audit.
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 85
� If required by the law ,prior approval of client & auditee is must.
H. Conducting audit follow -up
� Auditee to identify the corrective actions within a greed time.
� Audit team to verify completion and effectiveness.
Performing an Audit
Audit CriteriaReference against which conformity is determined.
� Standard
Initiating the Audit
Audit ScopeExtent and boundaries of the Audit including,
� Locations
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 86
� Standard
� Contractual Specification
� QMS Documentation
� QMS Planning
� Legislation or other requirement
� Locations
� Organizational Units.
� Activities & Processes covered
Performing an Audit
� Independence
� Team cohesion
� Training Needs
Considerations in selection of Team
� Quality Knowledge
� Technical Knowledge
� Legal Knowledge
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 87
� Training Needs
� Carrier Development
� Acceptability to Auditee
� Availability
� Language
� Legal Knowledge
� Knowledge of ISO 9001
� Audit skills
� Team Management Skills
Conducting Document Review
� Review Quality Manual ,Company Procedures &Practice s.
� Assess readiness for full systems audit.
� Focus on planning for on site audit.
� Establish personal contact and rapport with auditee .
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 88
� Establish personal contact and rapport with auditee .
� Validates scope ,purpose ,methods.
� Gather additional information.
� Identify potential problems.
Preparation for the ON -SITE Audit Activities
� Determine amount of work.
� Number of persons and days.
� Prepare plan.
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 89
� Prepare working documents.
� Keep auditee advised ,agree date and time.
� Logistic .
Performing an Audit
• Scope
• Criteria
• Dates & Duration
• Audit Team
Audit Plan
• Checklist
• Forms
• Standard
• Guidelines
Working Document
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 90
• Audit Team
• Detailed Timetable
• Matrix Plan
• Audit Team Requirements
• Remember to Cover Shifts
• Guidelines
Performing an Audit
• Audit Plan
• Timetable
• Matrix Plan
Notify the Auditee
• Dates & Duration
• Detailed Plan
• Matrix Plan
Notify the Team
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 91
• Matrix Plan
• Checklist
• Matrix Plan
• Individual Tasks
• Results of stage 1 audit
• Any special requirement
Conducting On -Site Activities
Meetings ,Communications and Field Visits
� Opening & closing Meetings are
formal Communications.
� Wash-up meeting reports ongoing
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 92
status ,findings and progress.
� Team liaison meeting help co-ordinate
&focus the audit team.
� Regular feedback to Auditees provides
on-going Communication.
Good Meeting Practice
� Be prepared.
� Have agenda ready.
� Take note of attendees.
� Seating plan.
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 93
� Seating plan.
Key Consideration –
What is this meeting intended to accomplish?
Opening & Closing Meetings
� Be on time.
� Entire team shall participate.
� Auditee senior management presence.
(minimum Management Rep. )
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 94
(minimum Management Rep. )
� Team Leader shall chair these meetings.
Opening Meeting Agenda
Introduce the Team Grading of NCR’s
Reason ,scope & criteria Confirm staff aware & avail able
Review audit plan & method Confirm logistics
Explain about sampling Confirm guides(if applicable)
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 95
Explain about sampling Confirm guides(if applicable)
Confidentiality Questions
Method of reporting
Closing Meeting Agenda
Thank the Auditee and Disclaimer
reintroduce the Team Overall Summary
Recap reason, scope & criteria Questions & Answers
Review audit plan & methods Corrective actions & time
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 96
Review audit plan & methods Corrective actions & time scale
Report the Observations, Recommendation
positive & negative Follow -up
Performing an Audit
Follow -up Action
� At agreed time
� Review of documentary evidence
� Re-audit on the site
Documentary Evidence
� Records
� Amended Procedures
� Photographs
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 97
� Re-audit on the site
� Only review of corrective actions
� Don’t start it all over again
� Photographs
� Videos
Performing an Audit
Follow -up Action Documentary Evidence
At agreed time
Review of documentary evidence
Re-audit on the site
Only review of corrective actions
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 98
Only review of corrective actions
Don’t start it all over again
What if they
are late?
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 99
Give them more
Time if possible
Nonconformity Report
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 100
Nonconformity Report
Nonconformity:
“ Nonfulfillment of a requirement ”
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 101
ISO 9000:2005
Form used for
Examination and Exercises
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 102
NCR
�Report what was wrong
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 103
�Report what was wrong
�Explain the requirement that was violated- Assist investigation
(Provide all relevant details of the incident)
- Avoid “inventing the requirements”
Scenario
Back office operations of a bank:
4 out of 18 operative seen entering client’s data i nto computers. They are found to be making a lot of errors in their work It was found that they were not
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 104
found to be making a lot of errors in their work It was found that they were not given any training & were doing the job on trial ba sis.
Further it was found that there were a few complain ts from customers regarding errors in their documents.
The Manager concerned said that there is no need of formal training as the data entry is a simple job and further verified by concern
Case Study 1
Area
Attribution
Grading
Problem
Requirement(s)
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 105
Requirement(s)
Signature
Scenario
Production- Light Machine Shop 1
On CNC turning Machine No 5- Dimensional inspection against drawing MUL/06/01 &05 (approved for production). Drawings show
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 106
drawing MUL/06/01 &05 (approved for production). Drawings show nominal dimensions only. Acceptable tolerances not specified in the drawings. Checked with design department and th ey too could not clarify the requirements for tolerances.
Case Study 2
Area
Attribution
Grading
Problem
Requirement(s)
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 107
Requirement(s)
Signature
Scenario
Customer information department of a Multinational Medical Insurance Company MIC Inc:
During routing surveillance audit the auditor obser ved that several of the customer’s documents (at least 50%) had specific Queries on
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 108
of the customer’s documents (at least 50%) had specific Queries on the settlement of insurance claims ranging from for tnight to month. There are no records to show that the organi zation has reviewed their capability to meet these requirement s but the insurance policies have been issued.
The Vice President (Claims) admitted that the organization is net geared up to settle claims within less than 2 month ’s period.
Case Study 3
Area
Attribution
Grading
Problem
Requirement(s)
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 109
Requirement(s)
Signature
Scenario
During the audit of the control room of an electric ity distribution company, auditor observed that the distribution cen tre captures and enters details of all power failures occurred.
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 110
When asked what is done with data , the shift super visor of the control room said that this data is submitted to th e owners and state electricity regulator on a regular basis. Not hing else is done with this data . The procedure of the company does not require anything more than this.
Case Study 4
Area
Attribution
Grading
Problem
Requirement(s)
© Intelux 2012, no part of this document may be circ ulated, quoted or reproduced without prior written approval of Intelux 111
Requirement(s)
Signature